Johnson & Johnson Careers

Compliance Manager

West Chester, Pennsylvania; Somerville, New Jersey
Compliance


Job Description

Requisition ID: 2136190108

DePuy Synthes, a member of the Johnson & Johnson Family of Companies is recruiting for a Compliance Manager to be based in West Chester, PA or Somerville, NJ.

 

The Compliance Manager serves as the Johnson & Johnson Medical Devices (JJMD) compliance representative for the External Strategic Collaborator (ESC).  He/she ensures that appropriate compliance communication channels are established and maintained between JJMD and ESC.  The Compliance Manager Oversees site compliance activities and ensures effective business wide compliance program that meets requirements with potential impact to JJMD products.  The Compliance Manager ensures that the Quality System (QS) is in compliance with the established QS requirements and Quality Agreement and determines the effectiveness of the Quality System through compliance programs.  The compliance manager has the necessary independence, authority and responsibility to communicate compliance problems according to the J&J escalation standard and Quality Agreement.  This position will partner with JJMD Compliance leaders and ESC Quality Operations & Compliance to ensure effective Internal Audit process, site inspection readiness and overall compliance support and guidance.

 

Principal Duties and Responsibilities:

    • Inspection readiness
    • Inspection response & subsequent follow up  
    • Inspection management
    • Commitment follow up
    • Readiness planning / transition for significant changes in Regulations (EuMDR, MDSAP)
    • Escalations
    • Compliance metrics collection, trending and reporting
    • ERC Follow up
  • Field Action Assessments
  • Joint supplier Review
  • Partner and Support Supplier Quality Program
  • Changes Control
  • Notified Body change management / Notification
  • Management of External Standards and Regulations site support
  • Purchasing control assessments


Qualifications
  • A Bachelor’s degree and a minimum of 6 years’ experience in a regulated industry is required
  • Demonstrated Quality and Compliance experience in domestic and international medical device, pharmaceutical and combination product quality systems is preferred
  • Direct experience with FDA inspections in a leadership role, is required
  • Certified Quality Auditor (CQA) is preferred
  • Experience with progressive quality systems, quality control, quality assurance, including hands on advanced quality systems compliance is required
  • Experience with Change Management as it relates to audit readiness is a plus
  • Experience working and managing in both a direct and highly matrixed global environment is preferred
  • Interpretation and application of QSR, ISO Standards and other relevant global regulations is preferred
  • The ability to continuously assess the effectiveness of functional processes and lead progressive improvement initiatives is required
  • Strategic mindset as it pertains to compliance programs with strong leadership ability, interpersonal, communication, and influencing skills is required
  • Strong collaboration skills, the ability to communicate written and verbally in a virtual global environment and to work effectively with cross-functional teams is required
  • Ability to analyze, balance, and prioritize risk is required
  • This position will be based in West Chester, PA or Somerville, NJ and may require up to 25% domestic and international travel, based on business needs.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



Primary Location
United States-Pennsylvania-West Chester-
Other Locations
United States-New Jersey-Somerville
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Compliance
Requisition ID
2136190108